Anti-tumor drug supervision in China from 2010 to 2024: the evolution and prospect of drug review standards

References

[1] Ning ZQ, Li ZB, Newman MJ, Shan S, Wang XH, Pan DS, et al. Chidamide (CS055/HBI-8000): a new histone deacetylase inhibitor of the benzamide class with antitumor activity and the ability to enhance immune cell-mediated tumor cell cytotoxicity. Cancer Chemother Pharmacol. 2012; 69(4): 901–909.

[2] Tang L, Zhou M, Xia L, Hao RM, Tong X, Chen DM, et al. Rethinking the marketing strategy of anti-tumor drugs by single-arm trials supported. Zhonghua Zhong Liu Za Zhi. 2022; 44(6): 587–592.

[3] Center for Drug Evaluation. Guidance for Pre-Marketing Authorization Application (MAA) Clinical Communication of Anti-tumor Drugs Supported by Single-Arm Trials for Marketing Authorization Application. Beijing. 2020. https://www.cde.org.cn/main/news/viewInfoCommon/e303bd3deb01db072c7b37cd46195a67

[4] Center for Drug Evaluation. Guidance for Pre-Pivotal Trial Clinical Communication on Anti-tumor Drugs Supported by Single-Arm Trials Before Entering Pivotal Trials for Marketing Approval. Beijing. 2020. https://www.cde.org.cn/main/news/viewInfoCommon/2a6d7894c0ee2aaa37fd1ca8e941cdab

[5] Center for Drug Evaluation. Guidance on the Applicability of Single Arm Trials to Support the Marketing Authorization Application of Anticancer Drugs Beijing. 2023. https://www.cde.org.cn/main/news/viewInfoCommon/9f0c25dee6ba6781af809b36cf682eb6

[6] National Medical Products Administration. The NMPA publicly solicited comments on the Procedures for Review and Approval of Conditional Marketing Approval Applications for Marketed Drugs (interim) (Revised Draft for Public Comments). Beijing. 2023. https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhqyj/20230825104212129.html

[7] Zou L, Qi Y, Jiang Y, Tang L, Du Y, Zhao B, et al. Criteria and regulatory considerations for the conditional approval of innovative antitumor drugs in China: from the perspective of clinical reviewers. Cancer Commun (Lond). 2023; 43(2): 171–176.

[8] Zhou S, Yang Z, Song Y, Huang G. Reform and Development of Innovative Drug Review and Approval in China: Taking Anti-Tumor Drugs as an Example. China Food Drug Administration. 2024; 0(6): 4–15.

[9] Chen F, Wendl MC, Wyczalkowski MA, Bailey MH, Li Y, Ding L. Moving pan-cancer studies from basic research toward the clinic. Nat Cancer. 2021; 2(9): 879–890.

[10] Center for Drug Evaluation. Guidance for the Application of Physiological Pharmacokinetic Models in Drug R&D for Pediatric Populations. Beijing. 2023. https://www.cde.org.cn/main/news/viewInfoCommon/c1ccd4f7d92531ead702938347b75874

[11] Blumenthal GM, Zhang L, Zhang H, Kazandjian D, Khozin S, Tang S, et al. Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis. JAMA Oncol. 2017; 3(8): e171029.

[12] Center for Drug Evaluation. Report on the Technical Review of the Application for Marketing of Inetetamab for Injection (CXSS1800023). Beijing. 2021. https://www.cde.org.cn/main/xxgk/postmarketpage?acceptidCODE=f8c13ebba436013210c31203a3f3101e

[13] Center for Drug Evaluation. Guidance for Clinical R&D of Antitumor Drugs Oriented by Clinical Value. Beijing. 2021. https://www.cde.org.cn/main/news/viewInfoCommon/ef7bfde96c769308ad080bb7ab2f538e

[14] State Administration for Market Regulation. Provisions for Drug Registration. Beijing. 2020. https://www.gov.cn/zhengce/zhengceku/2020-04/01/content_5498012.htm

[15] Center for Drug Evaluation. Guidance for Conditional Marketing Approval of Drugs (interim). Beijing. 2020. https://www.gov.cn/zhengce/zhengceku/2020-04/01/content_5498012.htm

[16] NMPA. Guidance for Clinical Trial Endpoints of Late-stage Non-Small Cell Lung Cancer. Beijing. 2019. https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=c696c202109132c21a5a89ad49410e96

[17] Center for Drug Evaluation. Guidance for Clinical Trial Endpoints of Late-stage Hepatocellular Carcinoma. Beijing. 2020. https://www.cde.org.cn/main/news/viewInfoCommon/2ab3ff01edb369c8bbec9285545c79f1

[18] Center for Drug Evaluation. Report on the Technical Review of the Application for Marketing of Dalpiciclib Tablets (CXHS2101006-8). Beijing. 2022. https://www.cde.org.cn/main/xxgk/postmarketpage?acceptidCODE=25fa5e5e5d7197ac7a1c1991b3861931

RIGHTS & PERMISSIONS

2024 The Author(s). Cancer Communications published by John Wiley & Sons Australia, Ltd. on behalf of Sun Yat-sen University Cancer Center.